Use in Pregnancy (Category B31): There are no adequate and well-controlled studies of micafungin in pregnant women.
Micafungin and/or its metabolites were shown to cross the placental barrier and distribute to the foetus in rats. No effects on embryo foetal development were observed in rats given IV doses of micafungin up to 32 mg/kg/day throughout organogenesis (2-3-fold the anticipated maximum clinical exposure, based on AUC). However, treatment of rabbits at doses of 32 mg/kg/day IV (2-fold the maximum anticipated clinical exposure, based on AUC) throughout organogenesis was associated with visceral abnormalities and increased abortion. Visceral abnormalities included abnormal lobation of the lung, levocardia, retrocaval ureter, anomalous right subclavian artery, and dilation of the ureter.
While animal studies are not always predictive of a human response, MYCAMINE should only be used during pregnancy if the potential benefit justifies the potential risk to the foetus.
1 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals have shown evidence of an increased occurrence of foetal damage, the significance of which is considered uncertain in humans.
Use in Lactation: Micafungin and its metabolites were excreted in the milk of lactating rats. In a pre- and postnatal development study in rats, doses of 32 mg/kg/day IV micafungin (resulting in 2-3-fold the anticipated maximum clinical exposure, based on AUC) were associated with reduced pup birth weights and a possible delay in the time of eyelid opening and balanopreputia cleavage.
It is not known whether micafungin is excreted in human breast milk. Therefore caution should be exercised when MYCAMINE is administered during breastfeeding.